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NCT01116752 · ClinicalTrials.gov registry record · Phase 3
Pediatric Intensive Care Units (ICUs) at Emory-Children's Center Glycemic Control: The PedETrol Trial
A Phase 3 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 3
- Development phase
- 153
- Enrollment target
NCT01116752: Completed Phase 3 study, sponsored by Indiana University.
NCT01116752 is a Phase 3 study that has completed, run by Indiana University. The registered enrollment target is 153 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01116752, a Phase 3 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 153 participants
- Enrollment target
Study Summary
The primary goal of this project is to determine whether normalizing hyperglycemia is a safe approach to improve multisystem organ function in critically ill children requiring intensive care. The will are conducting the "PedETrol" (the "Pediatric ICUs at Emory-Children's Center Glycemic Control: The PedETrol Trial) Trial, a 4-year single-center, prospective, randomized clinical trial to evaluate the outcome benefit, safety and resource utilization impact of maintaining strict glucose control in children with life-threatening conditions. \*\*\*This study is supported by an Research Project Grant (RO1 grant) (MRR) via the National Heart, Lung, and Blood Institute (NHLBI).
Primary Outcome
Determine the rapidity of recovery of organ function in critically ill children subject to either strict or conservative glycemic control by assessing organ function using Pediatric Logistic Organ Dysfunction (PELOD) scoring 6 days following development of hyperglycemia.
Interventions
- OTHER Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2010-08 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
What the finished NCT01116752 record still lists
NCT01116752 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring) is the first listed.
NCT01116752 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01116752 about?
NCT01116752 is a clinical study titled "Pediatric Intensive Care Units (ICUs) at Emory-Children's Center Glycemic Control: The PedETrol Trial". The primary goal of this project is to determine whether normalizing hyperglycemia is a safe approach to improve multisystem organ function in critically ill children requiring intensive care. The will are conducting the "PedETrol" (the "Pediatric ICUs at Emory-Children's Center Glycemic Control: Th...
What is the current status of trial NCT01116752?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 153 participants. The study started on 2010-08. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01116752?
The interventions under investigation include: Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring) (OTHER).
Who is sponsoring clinical trial NCT01116752?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01116752's enrollment target sits among peer trials
153 1510th of 2000 higher than 488 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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